NCT05245617

Observational Study on JuniOrtho Plating System for Deformities and Fractures Treatment in Lower Limb

A Single Center Post-market Clinical Follow up (PMCF) Observational Study Evaluating the Clinical Performance and the Safety Profile of the JuniOrtho™ Plating System™ (JPS) for the Treatment of Congenital Deformities and Fractures in Lower Limb of Pediatric and Adult Patients

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 30 (actual)
• Sponsor: Orthofix s.r.l. · Industry
• Sex: All
• Age: 1 Month
• Healthy volunteers: Not accepted

Summary

Orthofix Srl put the JPS on the European market (2019) by the mean of a pre-market clinical evaluation made under the Medical Device Directive (MDD) requirements that were based on the analysis of the scientific literature of equivalent devices. This study has been planned as part of the Orthofix Srl post-market active surveillance plan for the collection of data on both the clinical performance and the safety profile of the JPS in a representative population of Patients and users. The rationale of the proposed study is to update and support the pre-market clinical evaluation of the JPS with real-word-evidence clinical data, in order to confirm the benefit/risk ratio of this medical device and to keep the CE mark under Medical Device Regulation (MDR) requirements.

Detailed description

One selected site that is experienced in the treatment of pediatric and adult patients with bone deformities and fractures, where the usage of JPS is already part of the normal clinical practice, will participate in this study. Investigator will provide data for a maximum of 40 JPS implant cases satisfying inclusion and exclusion criteria (predicted drop out rate is 10%) that will contribute for at least 30 cases treated by JPS (note that some patients may contribute for more than one JPS case, according to how many JPS implants were received). For retrospective study cohort, who has previously had JPS implanted and follow-up assessment and JPS removal is done, the investigators shall purely collect clinical data from the medical record of the subjects, concerning the screening criteria, the surgery (MD application) and 4 following events: hospital discharge, first post-application control, bone consolidation assessment and device removal. Data from patients' observation are collected according to the site standard-of-care. Patients, who are prospectively enrolled in the study and have undergone JPS implantation, will have follow-up assessments, as described on Table 10.2, or until patient withdrawal. The patient data will be systematically collected by the investigator in eCRF. As per CIP, the subjects will not undergo additional visit nor non-invasive, invasive or burdensome procedures additional to those performed under the normal clinical practice.

Conditions

• Deformity
• Defect, Congenital
• Trauma

Interventions

Type	Name	Description
DEVICE	JuniOrtho™ Plating System™	The patient underwent surgery for the application of JPS for treatment of deformity or traumatic fracture.

Timeline

• Start date: 2022-11-16
• Primary completion: 2024-04-19
• Completion: 2024-04-19
• First posted: 2022-02-18
• Last updated: 2026-01-30
• Results posted: 2026-01-08

Locations

1 site across 1 country: Germany